CP-690-550 Ointment For Chronic Plaque Psoriasis

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NCT01246583

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Study Location
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;

- A target plaque of at least 9 sq. cm.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Demonstrates "rebound" or "flare" of chronic plaque psoriasis;


- Non plaque form of psoriasis;


- Currently have or history of psoriatic arthritis;


- Current drug induced psoriasis;


- Currently on systemic therapy or was on systemic therapy for psoriasis within the
previous 6 months;


- Currently on phototherapy for psoriasis or was on phototherapy within the previous 3
months

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE CP-690-550 Ointment For Chronic Plaque Psoriasis
Official Title  ICMJE A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: CP-690,550 Ointment 1
    2% CP-690,550 Ointment 1 twice daily for 4 weeks
  • Drug: Vehicle 1
    Vehicle 1 twice daily for 4 weeks
  • Drug: CP-690,550 Ointment 2
    2% CP-690,550 Ointment 2 twice daily for 4 weeks
  • Drug: Vehicle 2
    Vehicle 2 twice daily for 4 weeks
Study Arms  ICMJE
  • Experimental: Treatment Group A
    Intervention: Drug: CP-690,550 Ointment 1
  • Placebo Comparator: Treatment Group B
    Intervention: Drug: Vehicle 1
  • Experimental: Treatment Group C
    Intervention: Drug: CP-690,550 Ointment 2
  • Placebo Comparator: Treatment Group D
    Intervention: Drug: Vehicle 2
Publications * Ports WC, Khan S, Lan S, Lamba M, Bolduc C, Bissonnette R, Papp K. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013 Jul;169(1):137-45. doi: 10.1111/bjd.12266.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2012)		71
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)		72
Actual Study Completion Date  ICMJE November 29, 2011
Actual Primary Completion Date November 29, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
  • A target plaque of at least 9 sq. cm.

Exclusion Criteria:

  • Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
  • Non plaque form of psoriasis;
  • Currently have or history of psoriatic arthritis;
  • Current drug induced psoriasis;
  • Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
  • Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01246583
Other Study ID Numbers  ICMJE A3921116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP